Study on the Correlation Between Alveolar Macrophage-derived Autophagosomes and the Severity of Lung Injury in ARDS

NCT05101694 | Unknown

• 1 other identifier: 2021ZDSYLL215-P01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In the process of acute respiratory distress syndrome (ARDS), alveolar macrophages can secrete a large number of autophagosomes to mediate the inflammatory response of ARDS and aggravate the pathological damage of the lungs. At the same time, the meta-transcriptome can detect the expression of all genes without a reference genome. This study intends to explore that Whether the alveoli macrophage-derived autophagosomes are related to the severity and prognosis of ARDS, and try to construct a recognition model to predict the prognosis of ARDS.

Conditions

ARDS

Keywords

macrophage; autophagosome; gene

Outcome Measures

Primary Outcomes (2)

• The link between the proportion of macrophage-derived autophagosomes in alveolar lavage fluid of ARDS patients with the severity of ARDS

  Getting these data through Flow cytometer and analyzing the link between these data with the severity of ARDS

  at the first day of enrolling the patients

• Autophagosomes in alveolar lavage fluid of ARDS patients with the prognosis of ARDS

  Getting these data through Flow cytometer and analyzing the link between these data with the prognosis of ARDS

  at the twenty-eighth day of enrolling the patients

Secondary Outcomes (4)

• Autophagosomes and macrophage-derived autophagosomes in blood

  day 1，day 3 or day 7

• extracellular vesicles

  day 1，day 3 or day 7

• Mortality

  During hospitalization

• length of stay

  During hospitalization

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with ARDS in the Department of Critical Care Medicine, Zhongda Hospital, Southeast University from October 2021 to May 2022

You may qualify if:

• Age 18-85 years old
• Meet ARDS Berlin diagnostic criteria
• Artificial airway has been established (tracheal intubation, tracheotomy)
• Sign informed consent
• Within 7 days of diagnosis of ARDS

You may not qualify if:

• Younger than 18 years old or older than 85 years old
• Pregnant women, cancer and immune system diseases
• There are contraindications for bronchoscopy (poor oxygenation/severe heart disease, cardiac insufficiency/abnormal blood clotting, massive hemoptysis/aortic aneurysm risk of rupture, etc.)
• Patients undergoing other clinical trials
• Estimated survival time \<24h

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Nanjing Zhong-Da Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (13)

• Irish Critical Care Trials Group. Acute lung injury and the acute respiratory distress syndrome in Ireland: a prospective audit of epidemiology and management. Crit Care. 2008;12(1):R30. doi: 10.1186/cc6808. Epub 2008 Feb 29.

  PMID: 18312626 RESULT

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 RESULT

• Liu L, Yang Y, Gao Z, Li M, Mu X, Ma X, Li G, Sun W, Wang X, Gu Q, Zheng R, Zhao H, Ao D, Yu W, Wang Y, Chen K, Yan J, Li J, Cai G, Wang Y, Wang H, Kang Y, Slutsky AS, Liu S, Xie J, Qiu H. Practice of diagnosis and management of acute respiratory distress syndrome in mainland China: a cross-sectional study. J Thorac Dis. 2018 Sep;10(9):5394-5404. doi: 10.21037/jtd.2018.08.137.

  PMID: 30416787 RESULT

• Sakr Y, Francois B, Sole-Violan J, Kotfis K, Jaschinski U, Estella A, Leone M, Jakob SM, Wittebole X, Fontes LE, de Melo Gurgel M, Midega T, Vincent JL, Ranieri VM; SOAP and ICON Investigators. Temporal changes in the epidemiology, management, and outcome from acute respiratory distress syndrome in European intensive care units: a comparison of two large cohorts. Crit Care. 2021 Feb 25;25(1):87. doi: 10.1186/s13054-020-03455-8.

  PMID: 33632247 RESULT

• Pourfathi M, Kadlecek SJ, Chatterjee S, Rizi RR. Metabolic Imaging and Biological Assessment: Platforms to Evaluate Acute Lung Injury and Inflammation. Front Physiol. 2020 Aug 31;11:937. doi: 10.3389/fphys.2020.00937. eCollection 2020.

  PMID: 32982768 RESULT

• Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available.

  PMID: 28792873 RESULT

• Huang X, Xiu H, Zhang S, Zhang G. The Role of Macrophages in the Pathogenesis of ALI/ARDS. Mediators Inflamm. 2018 May 13;2018:1264913. doi: 10.1155/2018/1264913. eCollection 2018.

  PMID: 29950923 RESULT

• Dikic I, Elazar Z. Mechanism and medical implications of mammalian autophagy. Nat Rev Mol Cell Biol. 2018 Jun;19(6):349-364. doi: 10.1038/s41580-018-0003-4.

  PMID: 29618831 RESULT

• Mizushima N, Levine B. Autophagy in Human Diseases. N Engl J Med. 2020 Oct 15;383(16):1564-1576. doi: 10.1056/NEJMra2022774. No abstract available.

  PMID: 33053285 RESULT

• Wang J, Davis S, Zhu M, Miller EA, Ferro-Novick S. Autophagosome formation: Where the secretory and autophagy pathways meet. Autophagy. 2017 May 4;13(5):973-974. doi: 10.1080/15548627.2017.1287657. Epub 2017 Feb 15.

  PMID: 28287860 RESULT

• Gonzalez CD, Resnik R, Vaccaro MI. Secretory Autophagy and Its Relevance in Metabolic and Degenerative Disease. Front Endocrinol (Lausanne). 2020 May 5;11:266. doi: 10.3389/fendo.2020.00266. eCollection 2020.

  PMID: 32477265 RESULT

• Davis S, Wang J, Ferro-Novick S. Crosstalk between the Secretory and Autophagy Pathways Regulates Autophagosome Formation. Dev Cell. 2017 Apr 10;41(1):23-32. doi: 10.1016/j.devcel.2017.03.015.

  PMID: 28399396 RESULT

• Bel S, Pendse M, Wang Y, Li Y, Ruhn KA, Hassell B, Leal T, Winter SE, Xavier RJ, Hooper LV. Paneth cells secrete lysozyme via secretory autophagy during bacterial infection of the intestine. Science. 2017 Sep 8;357(6355):1047-1052. doi: 10.1126/science.aal4677. Epub 2017 Jul 27.

  PMID: 28751470 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and BALF

Study Officials

• Ling Liu, Dr

  Southeast University

  STUDY DIRECTOR

Central Study Contacts

Dong Xuecheng, bachelor

CONTACT

15850501101; xuechengdong2020@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: November 1, 2021
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: the data can be available before June 2023 and can be available for all the time
• Access Criteria: liulingdoctor@126.com

Locations

CN (1)